Stroke Clinical Trial
Official title:
Dietary Analyses in the Nurses' Health Studies and Health Professionals Follow-Up Study (Diabetes, Cardiovascular Disease, and Mortality)
To determine the relationships of a variety of nutrients, foods, and dietary patterns with the subsequent risk of developing type 2 diabetes, cardiovascular disease, and mortality in US men and women.
The Nurses' Health Study (NHS) consisted of 121,700 female registered nurses aged 30 to 55
years from 11 US states who were enrolled in 1976. The NHSII was initiated in 1989 with the
recruitment of 116,671 younger female registered nurses, 24 to 44 years of age, from 14
states. The Health Professionals Follow-up Study (HPFS) was established in 1986 and was
comprised of 51,529 US male health professionals ranging in age from 40 to 75 years at
enrollment from 50 states.
Study investigators sent follow-up questionnaires biennially to participants to update
information on past medical history as well as lifestyle factors. Validated food frequency
questionnaires (FFQs) were first sent in 1980 for the NHS, 1991 for the NHSII, and 1986 for
the HPFS. Dietary assessments have been updated every 2-4 years since baseline. The FFQs
collect information on average intake of each food item over the past year. It also specifies
a common serving size for each item. Participants could select from one of nine intake
frequency choices, ranging from less than once per month to six or more times per day.
Participants also provided information on current use and dose of multivitamins and use of
other vitamin supplements.
For these three cohorts, investigators repeatedly collected and updated information on
several anthropometric and lifestyle factors such as weight, smoking status, alcohol use,
coffee intake, and physical activity level. Information was also collected on several major
risk factors.
Study subjects reported new diagnoses biennially. After obtaining permission from
participants, their medical and pathological records were acquired. Study physicians blinded
to questionnaire information reviewed these records to confirm diagnoses of coronary heart
disease and stroke. Self-reported diabetes diagnoses are confirmed using a validated
supplementary questionnaire on symptoms, blood glucose levels, and medication use. Deaths are
identified through reports from next of kin, postal authorities, or by searching the National
Death Index.
All investigations regarding dietary factors in relation to type 2 diabetes, cardiovascular
disease, and mortality have been approved by the institutional review boards of both Brigham
and Women's Hospital and Harvard T.H Chan School of Public Health.
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